Italy ponders high-dose vitamin reclassification

Insiders said the recommendation had government backing and that other nutrients may follow, even though it appears the position goes against EU case law that recommendations be based on data-based health risk to EU populations.

The Italian Committee of Nutrition and Dietetics (ICND), which advises the country's Ministry of Health referenced an EU minimum​​ of 2.5 ug used for labelling purposes known as nutrition reference values (NRV), as evidence that products containing substantially more of the nutrient should be classed as medicines and require a prescription to access.

A translated document seen by NutraIngredients stated: “​Directive 2002/46/EC [​2002 EU Food Supplements Directive]​, article 5, states that maximum amounts of vitamins and minerals in supplements will also be set taking ‘due account’ of reference values ​​​for the population, and not only of safety.”​

“Given the persistent lack of [EU] harmonisation, considering that ίn cases of reasonable doubt between the possible classification of a product between food and drugs, pharmaceutical legislation prevails, the Committee believes that products with Β12 vitamin intake of 500 ug cannot be classified as food supplements for nutritional or physiological effects​."

‘only risk-based restrictions are acceptable’​​

Rome-based EU food law expert Luca Bucchini, PhD, from Hylobates Consulting, said the ICND position was a challenge to EU case law.

“This would be quite a new trend since, despite countries like Belgium having NRV-based maximum levels in their books, EU member states have granted exceptions given clear ECJ case law clarifying that only risk-based restrictions are acceptable,”​ he told us.

Dr Bucchini said the European Court of Justice (ECJ) case of the Commission versus Germany​ ​which dealt with the classification of garlic supplements, showed high-dose products could be sold as food supplements unless a health risk or pharmacological properties could be demonstrated.

“If Italy's stand goes unchallenged, in defiance of EU mutual recognition, it would mean that the single market is fragmented in an area where there was the most legal clarity," ​said Dr Bucchini.

“Especially in light of Brexit, it may mean that some member states are preparing to set low maximum levels for vitamins and minerals in food supplements, on the basis of NRVs, now that the UK has less voice in the matter.”​

When is a food a drug?

UK-based EU food law specialist Dr Mark Tallon, PhD, from legal Foods, said it was unlikely the Italian position would stand up in the ECJ.

"The proposal on B12 is based primarily on the 'rule of doubt' - food vs medicine - and this is likely a weak basis as if this goes to court the Italians must demonstrate that intake of 500mcg can restore, correct or modify physiological function by exerting a pharmacological, immunological or metabolic action,"​ Dr Tallon said.

"European case law tells us that where ingredients occur in foods, the ability to demonstrating a medicinal action/function is difficult. If it was accepted are we going to see the ban of shellfish or similar foods that may result in exceeding the 500 ug level?" ​

"The bigger concern is on the basis of a restriction due to safety concerns. In this instance it maybe possible to argue that a restriction on the free movement of high dose B12 foods can be justified. I believe if any legislation is set in place to restrict the dosing of B12 and if challenged by FBO or Member State then it will be a decision for the courts and potentially the European courts."​

Brex-vit?

On the matter of Brexit, London-based lawyer and partner at Eversheds, Owen Warnock, said the UK and other EU markets "could go either way".​

"We could see the UK taking a tougher stand on supplements than the rest of the EU, and indeed the same might apply to any other countries which also left,"​ Warnock opined.

"However this would only be so if the Brexit model ends up with exiting countries being outside the single market rather than, as with Norway, inside that market. Also in the UK at least I think that even if there were freedom for our laws to be tougher on supplements I detect little pressure for this to happen."​

He added: "On the other hand the UK and any other leavers might decide to be more liberal in relation to food supplements – although again this would only be possible if it followed a departure from the EU single market. States still within the EU would remain subject to EU law on this issue. ​

"As with many other areas, that harmonised food law is sometimes uncomfortable in particular aspects with certain member states who will try to find ways around it, but usually in the end the EC and the ECJ bring them in to line. I don’t really see the power of EU harmonisation of food law weakening."​

Existing recommendations

Last year the European Food Safety Authority (EFSA) recommended​​ an adequate intake (AI) of 4 μg but said data was lacking to establish a safe upper limit. Dr Bucchini speculated this lack of an upper limit was the reason the ICND was targeting vitamin B12 as some member states were selling B12 products with 1-5 mg doses.

At that time of EFSA's opinion, the Health Council of the Netherlands warned the opinion ignored how the nutrient impacted different age groups.

“Especially elderly are at increased risk of cobalamin deficiency, due to reduced absorption as a consequence of atrophic gastritis. This is not a situation that can be taken into account when setting DRV’s,” ​they wrote.

There are eight EU-approved health claims​​ for vitamin B12 including immunity, energy, psychological function and red blood cell formation.